[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11574-11579]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The ACTING PRESIDENT pro tempore. Under the previous order, the 
Senate will resume consideration of S. 1082, which the clerk will 
report.
  The bill clerk read as follows:

       A bill (S. 1082) to amend the Federal Food, Drug, and 
     Cosmetic Act to reauthorize and amend the prescription drug 
     user fee provisions, and for other purposes.

  Pending:

       Landrieu amendment No. 1004, to require the Food and Drug 
     Administration to permit the sale of baby turtles as pets so 
     long as the seller uses proven methods to effectively treat 
     salmonella.
       Stabenow amendment No. 1011, to insert provisions related 
     to citizens petitions.
       Brown (for Brownback/Brown) amendment No. 985, to establish 
     a priority drug review process to encourage treatments of 
     tropical diseases.
       Vitter amendment No. 983, to require counterfeit-resistant 
     technologies for prescription drugs.
       Inhofe amendment No. 988, to protect children and their 
     parents from being coerced into administering a controlled 
     substance in order to attend school.
       Gregg/Coleman amendment No. 993, to provide for the 
     regulation of Internet pharmacies.

  The ACTING PRESIDENT pro tempore. The Senator from Ohio.
  Mr. BROWN. Mr. President, we continue the discussion today on S. 
1082. I am joined by Senator Enzi as a cosponsor of that bill, with 
Senator Kennedy. We are considering several amendments this morning 
that are designed to and will increase access to lifesaving 
prescription drugs. I wish for a moment to talk about a couple of those 
amendments.
  One is the Stabenow/Thune amendment No. 1011, cosponsored by Senator 
Lott of Mississippi and by me, which will stop drug companies from 
intentionally jamming up the Food and Drug Administration approval 
process for generic drugs, exploiting the citizen petition process to 
block price competition in the marketplace.
  Free market economies rely on price competition. When brand-name drug 
companies block price competition, they are not only cheating generic 
drug manufacturers, they are cheating consumers, businesses, and tax-
funded health care programs. None of us can afford that.
  The Congressional Budget Office estimates the Stabenow amendment will 
save taxpayers hundreds of millions of dollars over the next 10 years. 
Those are just the savings that accrue to tax-funded health programs. 
There will also be significant savings to consumers and employer-
sponsored health plans.
  This amendment preserves the rights, as we should, of citizens to 
petition their government. But it stops the gaming of the patent system 
by the name-brand drug companies which have very effectively stymied 
price competition. I think unanimously in this body we support the 
whole idea of price competition.
  The savings of this bill will go to seniors and others who have seen 
large out-of-pocket expenses in their purchase of prescription drugs. 
The savings will go to businesses helping us globally compete better 
than we might otherwise. The savings will go to taxpayers, through a 
variety of different Government programs that help people buy their 
prescription drugs. So every Member's support is crucial on the 
Stabenow-Thune amendment.
  I want to highlight an amendment that has been offered by my 
colleague Senator Brownback and myself. According to the World Health 
Organization, more than 1 billion people--nearly one in every six 
people worldwide--are affected by at least one neglected tropical 
disease. In addition, neglected tropical diseases claim roughly 500,000 
lives each year.
  However, less than 1 percent of the 1,400 drugs registered between 
1975 and 1999--over a 25-year-period--fewer than 1 percent of the 1,400 
drugs registered treated such diseases.
  This disparity is clearly due to the lack of financial incentive for 
pharmaceutical companies to bring neglected tropical disease treatments 
to market because these diseases disproportionately affect low-income 
countries, with

[[Page 11575]]

the poorest of the poor in those countries needing those medicines, 
most of them in Africa.
  Creating incentives for companies to invest in treatments for these 
diseases is not only in our country's national interest, but it is 
consistent with our longstanding tradition of caring for those who are 
less fortunate around the world. In other words, it is consistent with 
American values.
  Senator Brownback's and my amendment would award a priority review 
voucher to any company that brings a neglected tropical disease 
treatment to market. Priority review is an existing FDA process by 
which drugs are reviewed in 6 months, as opposed to the average review 
time of 18 months, significantly speeding the process.
  The priority review voucher would be transferrable and could be 
applied to any drug in a company's pipeline. This amendment will help 
to bring about research and new drugs treating these tropical diseases 
and speed the process of getting them to market.
  This voucher, which would be worth hundreds of millions of dollars 
for a company with a new blockbuster drug, would also benefit 
consumers. That is because it would give consumers earlier access to a 
new prescription drug. Most importantly, creating incentives for 
pharmaceutical companies to develop and to manufacture neglected and 
tropical disease treatments will save lives.
  I commend Senator Brownback for his work on behalf of impoverished 
populations who desperately need our attention. He is offering Members 
of this body an opportunity to simultaneously save lives in developing 
nations, give U.S. consumers access to new medicines more quickly, and 
engage the drug industry in a win-win proposition.
  It is a rare opportunity. I urge Members on both sides of the aisle 
to support the Brownback-Brown amendment.
  I yield the floor and suggest the absence of a quorum.
  The ACTING PRESIDENT pro tempore. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  The ACTING PRESIDENT pro tempore. The Senator from North Dakota is 
recognized.
  Mr. DORGAN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. DORGAN. Mr. President, the Cochran amendment requires a 
certification by the Secretary of Health and Human Services which we 
know from previous experience now cannot or will not be made by the 
Secretary of Health and Human Services.
  Therefore, I was going to ask the Senator from Wyoming a couple of 
questions, if at some point he might come back so I can engage him in a 
colloquy.
  The point of the Cochran amendment is that it will now nullify the 
entire amendment that was offered by myself, Senator Snowe, and 33 
other Senators who had cosponsored the amendment. I wanted to point out 
that in the amendment, it not only allowed for reimportation of 
prescription drugs--FDA-approved prescription drugs from other 
countries whose chain of custody was identical or virtually identical 
to ours so that the American people would have access to lower priced, 
FDA-approved prescription drugs--but we also included in that 
amendment, which would now be nullified because the Secretary of HHS 
will not be able to certify, counterfeit-resistant technologies.
  Now, I believe those counterfeit-resistant technologies are as 
applicable to our existing drug supply domestically as they are to any 
potential imports that would be brought into this country.
  I want to read just a couple of comments about this. Then I would 
like, if the Senator from Wyoming would be willing, to entertain some 
questions or at least engage in a colloquy on this subject. I would 
like to discuss with him the provisions in the bill that would be 
nullified by Senator Cochran's amendment because the Secretary could 
not certify, and so all of the amendments that we offered would be 
nullified. The provisions dealing with counterfeit-resistant 
technologies, it seems to me, probably should proceed because all of us 
are concerned about the issue of counterfeit drugs, whether it is 
through reimportation or counterfeit drugs in the existing drug supply.
  All of the discussions about counterfeit drugs that have been had on 
the floor of the Senate have nothing to do with reimportation; it has 
to do with the existing circumstances. So the counterfeit-resistant 
technologies, that portion of the amendment--which will also now be 
nullified--I think should be restored. I have offered a second-degree 
amendment to do that, simply to restore for the current drug supply in 
this country the safety provisions that would exist with respect to the 
counterfeit-resistant technologies.
  Let me read it for a moment. The provisions in the amendment were, 
the packaging of any prescription drugs would incorporate, one, a 
standardized numerical identifier unique to each package of such drug 
applied at the point of manufacturing and repackaging, in which case 
the numerical identifier shall be linked to the numerical identifier 
applied at the point of manufacturing; and, two, overt optically 
variable, counterfeit-resistant technologies that are visible to the 
naked eye, providing for visual identification of product authenticity 
without the need for readers, microscopes, lighting devices, or 
scanners, similar to that used by the Bureau of Engraving and Printing 
to secure U.S. currency, that are manufactured and distributed in a 
highly secure, tightly controlled environment.
  But the point is, I held up a twenty-dollar bill yesterday on the 
floor of the Senate and said: This has designed into it--the 
architecture of this counterfeit-resistant bill has designed into it a 
lot of protections in order to prevent counterfeiting of the twenty-
dollar bill.
  We are all concerned about the counterfeiting of prescription drugs, 
so we have put a provision in the amendment that we had offered, 
something called counterfeit-resistant technology. My point is, it 
seems to me we should at least make that apply to the domestic drug 
supply, even if we have already made a decision we are going to nullify 
the opportunity for reimportation.
  We will come back to that decision later. The Senate will debate that 
again and vote on that again. But for now, at least, it seems to me we 
should not lose the provisions of that amendment dealing with 
counterfeit-resistant technologies.
  Might I ask the Senator from Wyoming, the ranking member on the 
committee, his feeling about adding that provision that would, I think, 
substantially safeguard the domestic drug supply?
  Mr. ENZI. Mr. President, I appreciate the question. I appreciate the 
effort that has gone into adding ways the drug supply can be more safe 
in the United States. Of course, we are interested in that. The primary 
focus of the bill was to make sure the U.S. drug supply was as safe as 
possible.
  There were a number of amendments, one of which was withdrawn last 
night, that dealt with Internet sales. That could have been Internet 
sales in the United States as well as Internet sales outside of the 
United States. The reason it was withdrawn is the sponsor of it did not 
want it to get polarized into a debate as to whether that would undo 
what you have been working on. It was not. It was to add some more 
safety and security.
  Senator Kennedy and I have been working on this FDA bill for over 
2\1/2\ years now. We also have been working on some things that deal 
with pedigree and licensure in the United States as well as outside of 
the United States. We did not put that in. We didn't want it to be 
something, again, that would polarize people and maybe distract from 
being able to do it at a very logical time.
  So most of our effort right now is to make sure we do not enter into 
some budget points of order, that we are able to accomplish the bill 
and get it to conference where additional changes will be made.

[[Page 11576]]

  Our committee works maybe differently from others; I am not sure. I 
know it works differently from the Banking Committee that I also serve 
on. It has been one of the most contentious committees in the Senate. 
But over the last 2\1/2\ years we have changed that perspective a bit 
and really accomplished a lot.
  One of the biggest changes we have had is the way that we do a bill. 
Before we tried to stuff it at every possible opportunity; that meant 
in committee as well. You will notice this bill had only 1 day of 
markup. That is phenomenal for that committee. Three days a week is not 
unusual for the committee. We got it out of there in 1 week, which 
helped us to understand the concerns of the people on the committee.
  We promised to work on that when it went to the Senate floor. We have 
worked on it after it came to the floor. More amendments have been put 
in. We have worked with people. Senator Durbin had one on food safety. 
We worked with him and got that in; anything that does not appear to 
polarize, does not appear to add budget points of order, and things 
that have been considered before, we are trying to work into this bill. 
New concepts, we would like to talk about them a little bit more, 
explore them a little bit more, but we want everything to be as safe as 
possible. That is what we are working for.
  There are some huge costs that may potentially be involved in what 
you are talking about there. If the costs add to the costs of drugs, 
then someone has to pay it. Then, perhaps, we will be making less 
access to drugs. We do not want that, and I know you don't want that. 
Your focus has been on getting lower cost drugs to everyone.
  It is the same with the amendment that Senator Stabenow has. We have 
worked on that for days. It is a concept that we have been working on 
before and held some hearings on. I think we have arrived at some 
compromises to put that in. We are trying to wind up with some 
bipartisan things that we can do to get it to conference where more can 
be done. And some of these issues we have revisited.
  We are one of the busy committees on the Hill. We are holding a 
hearing as we speak. I had to leave that to come over to the floor to 
do just exactly this.
  I appreciate the Senator's efforts and ideas and creativity. I hope 
he will work with us.
  Mr. DORGAN. I thank the Senator from Wyoming for his response. It is 
true the bill on the floor of the Senate is a bill dealing with drug 
safety. But I think it is also the case that a lot of the discussion on 
the floor of the Senate has been about counterfeiting and about the 
potential danger counterfeiting would pose with respect to 
reimportation, and also the danger counterfeiting poses with respect to 
the existing drug supply.
  If that is the case, it seems illogical to me not to include 
pedigrees and serial numbers and RFID technology and the latest 
counterfeit technology in this bill. What we had done with 33 of us 
cosponsoring the reimportation bill is, we understood with respect to 
reimportation you need to be sure it is safe before you proceed.
  So we drafted a section on that, consulting with all of the experts. 
We spent a lot of time on it. We have worked on it for a couple of 
years now. That section, it seems to me, would vastly improve the 
underlying bill. Maybe it is not a consensus. I understand the 
pharmaceutical industry does not want to do pedigree and serial 
numbers, and so on, the way we have described it. But it seems to me it 
certainly should be the case that we add as much as we can to this 
bill--not load it down but add as much as we can on the issue of 
protecting against counterfeit drugs, whether it is through 
reimportation or the domestic drug supply.
  I guess I do not quite understand--I don't believe there is a budget 
point of order. I don't believe we are talking about any dramatic new 
costs. In any event, I would expect we should not have a tradeoff of a 
less safe drug supply versus the cost of the drug. I think all of us 
want the same thing. I believe Senator Kennedy and Senator Enzi would 
both want the safest possible drug supply we could have.
  Again, I come back to this notion of, we spend a lot of time worrying 
about how to detect a counterfeit twenty-dollar bill, and we have 
engineered substantial safety precautions. Why should we not do the 
same with respect to this bottle of Lipitor, if I might have consent to 
show it again.
  This is produced in Ireland. It contains a 20-milligram tablet of 
Lipitor to lower cholesterol. Why would we not want something on this 
bottle from the manufacturer that gives us the opportunity to 
understand the pedigree, the serial number, and so on? There are some 
markings on it, but we can do much better. That is the purpose of my 
offering a second-degree amendment, to preserve the counterfeiting and 
safety standard a bipartisan group of us has created. I would be happy 
to yield for a response if the Senator wishes.
  Mr. ENZI. Mr. President, I would like to respond.
  I like his example of the twenty-dollar bill or any other 
denomination. This has nothing to do with the pharmaceutical companies. 
This is a discussion Senator Kennedy and I have had ongoing for a long 
time, and we brought in some technical people to figure out how we can 
provide that security in a number of different ways. The way that 
differs from the twenty-dollar bill is that for everybody who handles--
not everybody, most people--twenty-dollar bills on a regular basis, the 
same design stays in play for a long time. But with the pill bottle, 
maybe the first pill bottle one gets will be the only pill bottle. 
Having the knowledge of what exactly to look for on there is not 
something we teach in school or in pharmacies or anywhere else. It has 
to be something that people can tell whether it truly is. That is what 
adds to the cost when it comes to pharmaceuticals. We are looking at 
inventors who are coming up with different ways all the time to make 
things secure, not just medicines. We haven't found the answer yet.
  Mr. DORGAN. Might I ask the question, are you moving in your 
committee toward requiring a pedigree and serial numbers? Is that where 
you are going to move in committee to have consensus? That is what I 
understand.
  Mr. ENZI. Mr. President, that is correct. We have been working on a 
pedigree and licensure amendment--it is actually structured as a 
separate bill--in anticipation of trying to add to this when we can 
find a solution that we feel comfortable with, and we haven't gotten 
there yet. I think we are close, but we haven't gotten there yet. It 
has been a joint effort with Senator Kennedy and I and both our staffs.
  Mr. DORGAN. Mr. President, if I may further, this is the first I 
understand that there is an issue with the anticounterfeit measures we 
have put in our reimportation bill. We have the counterfeit-resistant 
technologies that we have put in the bill. I guess if I hear the 
Senator from Wyoming correctly, he is not comfortable with those at 
this point. I had thought the issue was generally the philosophy of 
reimportation and pricing. Then I think we have a deeper chasm than I 
expected. I thought there was generally consensus that the technology 
that now exists, whether it is RFID or lots of new things that are 
available, the technology that exists should be used with respect to 
the latest available technology to resist counterfeiting. I thought 
there was perhaps a consensus on that. Maybe I was wrong. If there is a 
disagreement about whether we should have standardized identifiers, 
then I suppose there should be some hearings on that. I had thought we 
were beyond that point.
  That was the purpose of my offering a second-degree amendment. I did 
not expect it would be controversial to apply, whether it is to the 
domestic drug supply or the potential reimportation at some future 
point, the counterfeit-resistant technologies that already exist to be 
made available if we simply require it.
  Mr. ENZI. Mr. President, another technicality that we work on on this 
and a principle we have established that works well for the committee 
is we try not to be ultraspecific on what

[[Page 11577]]

we are doing so that we are picking winners and losers. That is a 
difficulty we had with the amendment the Senator proposed as well. Not 
that it can't be worked with and come up with something that fits the 
criteria of the principle. One of the difficulties of debating things 
on the floor as a new amendment and unamendable is that usually there 
are other ideas, some principles, other ways of working with it that 
are very difficult to do from the floor standpoint.
  That is why we start with the markup and some of the other things and 
keep working with them. I think you have to admit this has been pretty 
progressive in trying to get something done. There hasn't been the 
effort to stall things out. There has been a lot of opportunities to do 
that, but we have been trying to keep things going and hope to get 
something finished up on this bill so it can get to conference.
  Mr. DORGAN. Mr. President, I certainly don't intend to stall this 
bill. This legislation is going to pass. I indicated yesterday I wanted 
to see what was in the managers' package. Several of the proposed 
amendments, even at that point when I saw the package, were still under 
some reform or some change. Having reviewed it now, I can tell my 
colleagues I have no difficulty with the baby turtle provision, the pet 
baby turtle provision. I considered that at great length last night. I 
stayed awake considering it. But I decided to support the baby turtle 
provision and the tanning bed provision, for that matter, along with 
ginseng. I understand these are things that are being adjusted in the 
managers' package.
  I have looked through it. I don't have a problem with the specifics 
of the managers' package. My issue today was to come to talk about the 
counterfeit-resistant technologies that will be available to fight the 
issue of counterfeit drugs. The reason I felt it important to do that, 
most of the discussion to defeat the Dorgan-Snowe amendment and to 
impose the Cochran amendment was because of the discussion on the 
floor, what if we get counterfeit drugs under this proposal. So the 
discussion was all about not the counterfeit drugs that have come in 
under the proposal but the counterfeit drugs that have already come in 
under existing circumstances. My thought is, if counterfeiting is a big 
problem, then the underlying bill dealing with drug safety should have 
the strongest possible provisions relating to counterfeit-resistant 
technologies. That is regrettably not the case.
  I will end up voting for this bill when we get to final passage 
because it is a step forward. But it is not out there where it ought to 
be with respect to counterfeit-resistant technologies. I understand 
part of the reason is the pharmaceutical industry is not supportive of 
moving as far as we should move. At any rate, I appreciate the Senator 
responding to me. Frankly, it is fine on the floor to have a 
discussion. I don't think all discussion ought to be somewhere in 
committee. We ought to have pretty interesting discussions on the floor 
about what is in a bill and what is not, what we ought to add that 
would improve it. But I appreciate the Senator from Wyoming responding 
to me. As I indicated, I have a second-degree amendment along with a 
couple of others.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Casey). The Senator from Ohio.
  Mr. BROWN. Mr. President, Senator Dorgan is offering an important 
compromise. He is saying we should at least preserve the drug safety 
provisions in his reimportation amendment. These provisions are the 
result of significant discussion with public safety experts, and I 
believe the Senate should support the Dorgan amendment. Whether we 
agree on the issue of reimportation--and there is clearly a split in 
this body--we do agree on the importance of safety in our domestic 
supply. There have clearly been attempts to counterfeit inside the 
domestic supply. The Dorgan amendment brings us to a place that can 
help us answer those questions. I think the opponents to reimportation 
are wrong, but I understand they raise issues of drug safety. Those 
same issues of counterfeiting are present in our domestic supply, as 
Senator Dorgan said, under the law, under the situation we are in 
today.
  It sort of begs the larger question of drug safety overall. One of 
the worst ways we compromise drug safety is by limiting access to 
affordable prescription drugs. That limitation of access is because of 
the high cost of prescription drugs. Too many of us know of situations 
where people have said to me, in Zanesville and Lima and Toledo and 
Cleveland: I had to cut a prescription in half so they last twice as 
long or I took the pills every other day. Until we can find ways, which 
this bill takes some steps in that direction with the citizen petition 
process and other things, of getting lower cost prescription drugs into 
people's hands when their doctors prescribe them, the reimportation 
issue was one way we could have done that better. I am hopeful we can 
work with Senator Dorgan on some of these issues to bring us to the 
point that we are satisfied that the domestic supply for prescription 
drugs is as safe as it can be.
  The PRESIDING OFFICER. The Senator from Wyoming.
  Mr. ENZI. Mr. President, I thank the Senator from Ohio for his 
comments. But I wish to give a little bit more of an answer to the 
Senator from North Dakota, who has invested a lot of time and effort 
over the years in a variety of these issues that deal with the safety 
of our drug supply. I have to tell him, we got his second-degree 
amendment. Anything we have had has been a very cursory look. We are 
willing to sit down. We hope his staff will sit down with my staff and 
take a look at it and see what can be done.
  Mr. DORGAN. Might I point out, the second-degree amendment is 
language taken out of the Dorgan-Snowe bill that we filed months and 
months ago. It is identical language with respect to counterfeit-
resistant technology. It is not new language.
  Mr. ENZI. Mr. President, I am hoping that since we did not have a 
chance on drug importation--and I wish to make the point that that is 
importation, not reimportation--we didn't have a chance to sit down and 
work on that and work through it and see what changes could be made, it 
would only be logical that for a portion of that, we probably ought to 
sit down and look at it. We are never sure on a second-degree amendment 
whether it is exactly the same, but we didn't have the opportunity to 
work on it with the Senator. I think all the staffs that have been 
working on this have been working in a bipartisan way to come up with a 
solution. We will take a look at that specifically and see what can be 
done with it.
  I yield the floor.
  The PRESIDING OFFICER. The assistant majority leader.
  Mr. DURBIN. Mr. President, I have an amendment which I filed last 
week with Senator Bingaman on conflict-of-interest issues before the 
advisory committees of the Food and Drug Administration. I understand 
there may be an objection--I hope there is not--to setting aside the 
pending amendment and calling this one up for consideration. I don't 
want to catch anyone off guard with my request. I hope the Senator from 
Wyoming will note what I am about to request. If it is not consistent 
with his current wishes, I am asking unanimous consent that the pending 
amendment be set aside and that we move to amendment No. 1034 which I 
have filed at the desk.
  The PRESIDING OFFICER. Is there objection?
  Mr. ENZI. Reserving the right to object, there are several other 
people in that same position of wanting to call up amendments. We are 
trying to come up with a logical order, so I do object.
  The PRESIDING OFFICER. Objection is heard.
  Mr. DURBIN. I thank the Senator. I wouldn't take it personally. The 
issue I am raising here needs to be dispelled.
  What is the Food and Drug Administration? It is a relatively small 
Federal agency with a huge responsibility. We spend about $1.7 billion 
a year on the Food and Drug Administration in a huge Federal budget. 
This tiny agency is responsible for the safety of about 25 percent of 
all that we purchase as

[[Page 11578]]

Americans. They have responsibility when it comes to drugs, devices, 
biologics, food, veterinary medicines, all sorts of things, equipment. 
This small agency has a huge responsibility. We give them more and more 
things to do, and we trust the integrity of the Food and Drug 
Administration. We believe the Food and Drug Administration giving its 
approval means something. We can trust it. They have reached a decision 
that something we are about to buy is safe and effective. For most 
Americans, that is the seal of approval.
  How do they reach that level of integrity? They set up advisory 
committees. These are the wisest men and women they can find who take a 
close look at each one of the things they review and inspect to 
determine whether they truly are safe and effective. It is kind of a 
jury. The jury may be 10, 20, 30 different people who sit and make a 
decision.
  These decisions are critically important. I don't think I overstate 
it when I say these decisions are life-and-death decisions. They will 
decide that a certain pill which a pharmaceutical company says will 
help you with your heart condition, in fact, is safe to take and is 
effective, it will do what it is supposed to do. If they make a bad 
decision and the pill is not safe, a person's health can be 
jeopardized. So truly these are life-and-death decisions the advisory 
committees make at the Food and Drug Administration. In addition, these 
are very important economic decisions. Giving the seal of approval for 
a new drug means for that drug company the potential of making 
millions, if not billions, of dollars. So the stakes are high. Each 
time the advisory committee makes a decision, they know lives are on 
the line, and they also know a thumbs-up and a decision of approval can 
mean the stock of this company is going to rise, their profits will 
rise, they will make more money for shareholders, and they will have 
more money for research. It is a big undertaking.
  So it is not unfair for us to ask: Who are the people who sit on 
these advisory committees? Who are the people who are the jurors who 
try to impartially look at these issues and decide what is best for the 
American people?
  Well, it turns out we have had some problems--some significant 
problems--in the past. One would think it would be obvious to us that 
we don't want to appoint people to sit on the juries, on the advisory 
committees, who have a conflict of interest. What about someone who is 
on the payroll of the pharmaceutical company that wants a drug 
approved; would you want that person sitting on the advisory committee? 
What about someone who has earned $50,000 coincidentally speaking to 
this company's annual retreat in some Caribbean island; would you want 
that person on the advisory committee? What about someone who is on the 
payroll receiving money from a company that can stand to make millions 
of dollars if the decision goes the right way? The natural human 
reaction is: Well, shouldn't those people sit somewhere else? They 
shouldn't really be in the room if we are talking about their employer, 
if we are talking about someone who has paid them money. They shouldn't 
be part of this, should they? We want people sitting in that room who 
don't have any conflict of interest or any vested interest in the 
decision. We want people who are truly objective, dispassionate, and 
truthful. I think most Americans would agree. That is pretty obvious.
  Well, it turns out that over time the Food and Drug Administration 
got a little bit lax, a little bit sloppy. Back 7 or 8 years ago, USA 
Today published a dramatic expose about these advisory committees. They 
came to the conclusion that the experts sitting on these advisory 
committees who were supposed to be independent many times had a direct 
financial interest in the decision they were about to make. How often 
did it occur? In 92 percent of the advisory committee meetings--this 
goes back 7 or 8 years now, but in 92 percent of the meetings, at least 
one member sitting in that room deliberating had a financial conflict 
of interest. At more than half of the meetings, half or more of the 
members of the committee had a conflict of interest. What difference 
does it make? Does it make any difference if the person deciding the 
fate of a product that means profit or loss for a major corporation is 
on the payroll of that corporation? I think it does. It turns out it 
was a problem then, which the Food and Drug Administration started to 
address but, unfortunately, has not addressed effectively.
  Last week, a study by the New England Journal of Medicine, widely 
recognized and respected, examined the pharmaceutical industry's 
financial ties to doctors. Here is what they found:

       More than one-third of doctors report being reimbursed by 
     the drug industry for the cost of attending professional 
     meetings and continuing medical education; and almost 30 
     percent said they had been paid for consulting, giving 
     lectures, or signing up patients for clinical trials.

  So when it comes to doctors in general, it turns out that a third of 
them have a conflict of interest. So any patient walking into a 
doctor's office and the doctor says: You know, I think you should take 
XYZ drug, you would like to believe that doctor made that decision 
because they think that is the best drug for you or a member of your 
family. It is worrisome that in some instances, these doctors have a 
conflict of interest.
  The New England Journal of Medicine also went on to say, in the words 
of a prominent Harvard expert, Jerry Avorn, the ``penetration of 
commerce into the province of science'' causes great concern. It is the 
same issue here when it comes to these advisory committees.
  Now, the argument that comes back from the FDA and from the 
pharmaceutical industry is there just aren't enough smart people out 
there. We have to turn our employees and people we have on the payroll 
and people we have paid money to into these advisory committees because 
there aren't enough good people out there to sit on these advisory 
committees.
  Well, I think the New York Times made a good observation when it 
comes to that. Here is what they said:

       Unless the Food and Drug Administration makes a more 
     aggressive effort to find unbiased experts or medical 
     researchers to start severing their ties with industry, a 
     whiff of bias may taint the verdicts of many advisory panels.

  Here is what they have found over and over again: These conflicts of 
interest can cause a problem.
  Let's be very specific. In February of 2005, an FDA advisory 
committee considering the painkillers Vioxx, Bextra, and Celebrex, 
whether they should be sold to the public. There were 10 scientists 
sitting on that advisory committee who had conflicts of interest. They 
had some financial connection with the companies that made the products 
they were judging. Had the votes of those 10 scientists been excluded 
because of their conflicts of interest, the panel would have favored 
withdrawing Bextra from the market and blocking the return of Vioxx. 
Instead, with the 10 conflicted scientists and experts, they voted that 
the drugs return to the market. These drugs were very dangerous. People 
were having heart problems and other medical difficulties. They should 
never have been brought back to the market.
  What impact did the presence of these people with conflicts of 
interest have on the deliberations? It could not have been positive. It 
could not have been objective. They came to this with some financial 
interest, at least in the companies that were affected by the decision.
  Here is what my amendment does. The amendment says the Food and Drug 
Administration would be limited to only one waiver per advisory 
committee meeting.
  Mr. President, I understand under a previous consent order that we 
are moving at 12:15 to the consideration of a judge who will be voted 
on in 20 minutes, Judge Kapala of Illinois. I would like to have the 
time start on that. I ask unanimous consent to close my remarks on my 
amendment, say a few words about Judge Kapala, and then the remaining 
10 minutes for Senator Specter to speak.
  The PRESIDING OFFICER. Is there objection?

[[Page 11579]]

  Without objection, it is so ordered.
  Mr. DURBIN. Mr. President, I will be very brief because I see Senator 
Specter is on the floor.
  So what I am trying to do is make sure we only have one waiver per 
meeting, one person sitting on that advisory committee per meeting who 
might have a conflict of interest.
  We go on to say that any person with a financial interest could 
provide information to an Advisory Committee but can't be participating 
in or voting on the final decision. I think that only makes sense.
  The third thing we say is that the Food and Drug Administration has 
to actively promote more objective scientific experts without conflicts 
of interest.
  I don't think this is a radical proposal. Don't we want peace of mind 
at the end of the day that the advisory committee has made a decision 
based on science and medicine and what is good for America as opposed 
to the bottom-line profit-and-loss statement of the pharmaceutical 
company?
  There is a lot of discussion on this floor about the safety of drugs 
and the products that the FDA considers. I hope this amendment, which 
is critical to the integrity of the FDA, is approved by my colleagues 
on a bipartisan basis. I hope to offer this amendment tomorrow after we 
have gone through this rough procedural patch.

                          ____________________